Evaluation de l'intérêt d'un traitement par hydroquinidine pour la prise en charge des patients atteints d'un syndrome de Brugada à risque rythmique élevé et implantés d'un défibrillateur - QUIDAM

• Conditions: Patients with syndroma of Brugada who have an automatic implantable cardiac defibrillator; MedDRA version: 9.1Level: LLTClassification code 10059027Term: Brugada syndrome

• Registration Number: EUCTR2008-000994-39-FR
• Lead Sponsor: Centre Hospitalier Universitaire de Nantes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Criteria for inclusion: Patients aged 18 or > 18, presenting a type I Brugada syndrome, having an Implantable Automatic Defibrillator (IAD) and being either symptomatic [ previous occurrence of cardiac arrest or ventricular fibrillation reduced by the IAD, OR previous occurrence of syncope suggesting cardiac rhythm trouble] or either asymptomatic, all patients being affiliated to social security, having given their written informed consent, having no known allergy to hydroquinidine.
Criteria for randomization :
- Those above listed
- For patients with asymptomatic Brugada syndrome: positive electrophysiological exploration at the visit of inclusion
- Absence of hypersensitivity reaction after intake of one capsule of hydroquinidine
- No relevant abnormality in the electrocardiogram after 3 to 5 days of hydroquinidine treatment
- No relevant abnormality in blood formula
The study will allow the randomization of:
- 60 patients with symptomatic type I Brugada syndrome having presented a cardiac arrest or a ventricular fibrillation reduced by the IAD
- 70 patients symptomatic type I Brugada syndrome who have presented a syncope suggesting cardiac rhythm trouble
- 70 patients asymptomatic but with spontaneous type I electrocardiogram and for which the electrophysiological exploration induced a severe rhythm trouble

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Criteria of non inclusion :
- Patients not presenting the inclusion criteria
- Pregnancy or lactation
- Female of procreating age without contraceptive methods
- contra-indications to the use of hydroquinidine (ex: intolerance to fructose, myasthenia,…)
Criteria for non randomization :
- Those above listed
- Patient with asymptomatic Brugada syndrome presenting a negative electrophysiological exploration at the visit of inclusion
- Hypersensitivity reaction after intake of one capsule of hydroquinidine
- Relevant abnormality in the electrocardiogram after 3 to 5 days of hydroquinidine treatment
- Relevant abnormality in blood formula

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified